The fraud of the FDA approval is written into the document:
"We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion. [...]
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and ***identify an unexpected serious risk of subclinical myocarditis.***
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks."
https://www.fda.gov/media/151710/download
There isn't even any need for a whistleblower.
Sep 23, 2021
at
4:31 PM
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